CDRHNew - News and Updates
A comprehensive list of the latest CDRH updates.
This Week in CDRH
March 31, 2023
- Updated Emergency Use Authorizations
- Revised Emergency Use Authorizations
- LumiraDx SARS-CoV-2 Ag Test (LumiraDx UK Ltd.)
- Sampinute COVID-19 Antigen MIA (Celltrion USA, Inc.)
- Bio-Speedy Direct RT-qPCR SARS-CoV-2 (Bioeksen R&D Technologies Inc.)
- Sofia 2 Flu + SARS Antigen FIA (Quidel Corporation)
- Sienna-Clarity COVID-19 Antigen Rapid Test Cassette (Salofa Oy)
- NIDS COVID-19 Antigen Rapid Test Kit (ANP Technologies, Inc.)
- QuickVue At-Home COVID-19 Test (Quidel Corporation)
- Consumer Information: RelayPro Thoracic Stent-Graft System - P200045/S002 (Bolton Medical, Inc.)
- Consumer Information: CALCIVIS Imaging System - P170029 (CALCIVIS Limited)
- Consumer Information: VENTANA PD-L1 (SP263) Assay - P160046/S013 (Ventana Medical Systems, Inc.)
- Problems Reported with Essure (Updated
- FDA Activities Related to Essure (Updated)
- Expiration Dates Extended for Three OTC COVID-19 At-Home Tests (OHC COVID-19 Antigen Self Test, Flowflex COVID-19 Antigen Home Test, InteliSwab COVID-19 Rapid Test)
- Class I Recall by Datascope/Getinge of Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown After PCBA Communication Loss
March 30, 2023
- Revised Emergency Use Authorizations
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions - Draft Guidance for Industry and Food and Drug Administration Staff
- CDRH Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices
- Webinar - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning-Enabled Device Software Functions Draft Guidance - April 13, 2023
- Evaluation of Safety Concerns with Certain Dental Devices Used on Adults – FDA Safety Communication
- Medical Device Development Tool (MDDT)
- New tool: Computational Tool Comprising Visible Human Project Based Anatomical Female CAD Model and Ansys HFSS/Mechanical FEM Software for Temperature Rise Prediction near an Orthopedic Femoral Nail Implant during a 1.5 T MRI Scan
March 29, 2023
- Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act - Guidance for Industry and Food and Drug Administration Staff
- Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)
- Cybersecurity (Updated)
- Voluntary eSTAR Program (Updated)
- Federal Register: Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedures
- Federal Register: Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures
- Federal Register: Determination of Regulatory Review Period for Purposes of Patent Extension: M6-C Artificial Cervical Disc
- Federal Register: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems under the Federal Food, Drug, and Cosmetic Act
March 28, 2023
- Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
- Revised Emergency Use Authorizations
- Federal Register: Premarket Approval of Medical Devices
- Federal Register: Testing Communications by the Center for Devices and Radiological Health
- Federal Register: Orthopedic Non-Spinal Bone Plates, Screws, and Washers-Premarket Notification (510(k)) Submissions
March 27, 2023
- CLIA Waived - Sysmex XW-100 CW210002 (Updated)
- New Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- General Considerations for Animal Studies Intended to Evaluate Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff
- CDRH Learn (Updated)
- Presentation, Transcript, and Printable Slides: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkeypox (mpox) and COVID-19 - March 22, 2023
- Federal Register: Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway
- Federal Register: General Considerations for Animal Studies Intended to Evaluate Medical Devices
March 24, 2023
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) - Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff
- Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023
- FDA Issues Final Guidances to Assist with Transition Plans for COVID-19-Related Medical Devices
- FAQs on Emergency Use Authorizations (EUAs) for Medical Devices Related to COVID-19 (Updated)
- Importing Medical Devices Relating to COVID-19 (Updated)
- Diagnostic Data Program
- Federal Register: Transition Plan for Medical Devices Issued Emergency Use Authorizations Related to Coronavirus Disease 2019
- Federal Register: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 Public Health Emergency
March 23, 2023
- Reissued Emergency Use Authorization
- Updated Emergency Use Authorizaiton
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
- Risks with Exactech Joint Replacement Devices with Defective Packaging – FDA Safety Communication
March 22, 2023
- CorDx COVID-19 Ag Test (CorDX, Inc.)
- MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
- Status COVID-19/Flu A&B (Princeton BioMeditech Corp.)
- BD Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson and Company (BD))
- ePlex Respiratory Pathogen Panel (GenMark Diagnostics, Inc.)
- TaqPath COVID-19 Fast PCR Combo Kit 2.0 (Life Technologies Corporation)
- TaqPath COVID-19, FluA, FluB Combo Kit (Thermo Fisher Scientific)
March 21, 2023
- New Emergency Use Authorization
March 20, 2023
- Send and Track Medical Device Premarket Submissions Online: CDRH Portal (Updated)
- Pediatric X-ray Imaging (Updated)
- Microwave Ovens (Updated)
- Federal Register: Medical Devices: Technical Amendments
March 17, 2023
- Revised Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- March 22 Will Be the Last Recurring Virtual Town Hall in the Series on Test Development and Validation During Public Health Emergencies – Mpox and COVID-19
- Class I Recall: Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown Coiled Cord Connection Failure
March 16, 2023
- Revised Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Ejection Fraction Tool (ELEFT) (Anumana, Inc.)
- Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
March 15, 2023
March 14, 2023
- Revoked Emergency Use Authorizations
- Idylla Ebola Virus Triage Test (Biocartis NV)
- FilmArray NGDS BT-E Assay (BioFire Defense, LLC)
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
March 13, 2023
- New Emergency Use Authorization
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Public Workshop - Appropriate Use of Consensus Standards - 12/07/2022 (Transcript Added)
- Joint Public Workshops - Medical Devices for Opioid Use - 11/07-08/2022 (Transcript Added)
March 10, 2023
- Consumer Information on: Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System - P160043/S058 (Medtronic Vascular)
- Revised Emergency Use Authorization
- Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
- Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Custom Device Reporting
March 9, 2023
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Frequently Asked Questions About MQSA (Updated)
- Federal Register: Mammography Quality Standards Act
- Federal Register: Emergency Use Authorization: Certain Medical Devices during COVID-19
- Federal Register: In Vitro Diagnostic Device in Response to an Outbreak of Mpox
March 8, 2023
- Consumer Information on: StableVisc and TotalVisc Ophthalmic Viscosurgical Device - P220009 (Bausch Health Companies, Inc.)
- Updated Emergency Use Authorization
- In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 (Updated)
- In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2 (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210033 and DEN220039 added)
- UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication
- CDRH Statement: CDRH Updates Safety Communication for Squamous Cell Carcinoma (SCC) in Scar Tissue around Breast Implants
- Federal Register: Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
March 7, 2023
- CDRH Statement on Emergency Use Authorization of Lucira Health’s COVID-19 & Flu Home Test
- Meeting Notice: April 20, 2023 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
- CDRH's Experiential Learning Program (Updated)
- Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health Care Providers
March 6, 2023
- Revised Emergency Use Authorizations
- Celltrion DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
- Celltrion DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
- Sofia SARS Antigen FIA (Quidel Corporation)
- VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (Ortho Clinical Diagnostics, Inc.)
- Omnia SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC.)
- Reissued Emergency Use Authorizations
- Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19 (Updated)
- Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
March 3, 2023
- Updated Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Speedy Swab Rapid COVID-19 Ag Self-Test (Watmind USA) - extended expiration dates
- Pruebas de COVID-19 sin receta médica o de venta libre para diagnóstico en el hogar (Actualizado)
- COVID-19 y prueba casera de la gripe de Lucira (Lucira Health, Inc.)
- Autodiagnóstico COVI-Go SARS-CoV-2 Ag (Mologic, Inc.)
- Prueba casera de GenBody para el COVID-19 Ag (GenBody Inc.)
- Prueba auto-diagnóstico rápido del antígeno CLINITEST para el COVID-19 (Siemens Healthineers)
March 2, 2023
- MDUFA Reports
- MQSA National Statistics (Updated)
March 1, 2023
- Updated Emergency Use Authorization
- Total Product Life Cycle Advisory Program (TAP) (Updated)
- Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility with HLS Set Advanced - Letter to Health Care Providers
February 28, 2023
February 27, 2023
- Revised Emergency Use Authorization
- Adult Portable Bed Rail Safety (Updated)
- Safety Concerns about Adult Portable Bed Rails (Updated)
- Recommendations for Consumers and Caregivers about Adult Portable Bed Rails (Updated)
- Recommendations for Health Care Providers Using Adult Portable Bed Rails (Updated)
- Information for Manufacturers of Bed Rail Products (Updated)
- How to Report a Problem or Complaint about Bed Rails (Updated)
- Bed Rail Safety Activities (Updated)
- Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration- Letter to Health Care Providers
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220063 added)
February 24, 2023
- New Emergency Use Authorization
- Revised Emergency Use Authorization
- Updated Emergency Use Authorization
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220065 added)
February 23, 2023
- Revised Emergency Use Authorizations
- Consumer Information on: Guardant360 CDx - P200010/S010
- Evaluation of Airborne Chemicals from Neonatal Incubators – Letter to Health Care Providers
- Center for Devices and Radiological Health (CDRH) Compliance Programs (Updated)
- Update: Reduce the Risk for Medical Device Misconnections
February 22, 2023
- New Emergency Use Authorization
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210022 added)
- CDRH Learn (Updated)
- Presentation, Transcript, and Printable Slides: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkeypox (mpox) and COVID-19 - February 15, 2023
- ASCA-Accredited Testing Laboratories (Updated)
February 21, 2023
- New Emergency Use Authorization
- Revised Emergency Use Authorization
- Reissued Emergency Use Authorizations
- Terminated Emergency Use Authorization
- Appendix A: Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Updated)
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) - Guidance for Industry and Food and Drug Administration Staff
- Medical X-Ray Imaging Devices Conformance with IEC Standards - Guidance for Industry and Food and Drug Administration Staff
- Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices - Guidance for Industry and Food and Drug Administration Staff
- Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff
- Assembler's Guide to Diagnostic X-Ray Equipment - Guidance for Industry and Food and Drug Administration Staff
- Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff
- Medical X-ray Imaging (Updated)
- Does the Product Emit Radiation? (Updated)
- Fluoroscopy (Updated)
February 17, 2023
- Updated Emergency Use Authorization
- Network of Experts Program: Connecting the FDA with External Expertise (Updated)
- Federal Register: Premarket Notification Procedures
- Federal Register: Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic Power; Withdrawal
February 16, 2023
- Revised Emergency Use Authorizations
- Revoked Emergency Use Authorizations
- SARS-CoV-2 NGS Assay (Twist Bioscience Corporation)
- Babson Diagnostics aC19G1 (Babson Diagnostics, Inc.)
February 15, 2023
- Revised Emergency Use Authorizations
- Aptima SARS-CoV-2/Flu assay (Hologic, Inc.)
- Fosun COVID-19 RT-PCR Detection Kit (Fosun Pharma USA Inc.)
- Reissued Emergency Use Authorizations
- For consumer information: Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems - P010032/S189 (Abbott Medical)
- Class I Recall: GE HealthCare Recalls Nuclear Medicine 600/800 Series Systems for Risk of Detector Fall That May Injure Patients
February 14, 2023
- Revised Emergency Use Authorization
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
February 13, 2023
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Nucleic Acid Based Tests (Updated)
- Federal Register: Medical Device Labeling Requirements; Unique Device Identification
February 9, 2023
- Updated Emergency Use Authorization
- Medical Device Material Safety Summaries (Updated)
- Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
- Extended Expiration Date: CareStart COVID-19 Antigen Home Test and On/go COVID-19 Self-Test
- Personal Protective Equipment EUAs - Appendix A: Authorized Surgical Masks (Updated)
- Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication (Updated)
- FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls (Updated)
February 8, 2023
- New Emergency Use Authorization
- Personal Protective Equipment EUAs - Appendix A: Authorized Surgical Masks (Updated)
- Universal Meditech Inc. Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA
February 7, 2023
- New Emergency Use Authorizations
- Revised Emergency Use Authorization
- CDRH Petitions (Updated)
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Mammography Facility Adverse Event and Action Report – February 7, 2023: Advanced Women Imaging
- Mammography Facilities with Revoked MQSA Certificate (Advanced Women Imaging 02-07-23)
- Updated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJ
February 6, 2023
- Medical Devices Resources for Consumers (Updated)
- Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220044 added)
February 3, 2023
- Revised Emergency Use Authorization
- 510(k) Third Party Performance Metrics and Accreditation Status (Updated)
February 2, 2023
- Revoked Emergency Use Authorizations
- Advanta Dx SARS-CoV-2 RT-PCR Assay (Standard BioTools Inc.)
- Advanta Dx COVID-19 EASE Assay (Standard BioTools Inc.)
- BinaxNOW COVID-19 Ag 2 Card (Abbott Diagnostics Scarborough, Inc.)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220014 added)
- Accreditation Scheme for Conformity Assessment (ASCA) 2022 Annual Report
- MedSun Newsletter - February 2023
February 1, 2023
- For Consumer information: FlexAbility Abalation Catheter, Sensor Enabled - P110016/S080 (Abbott Medical)
- CDRH's Experiential Learning Program (Updated)
- Historical Information about Device Emergency Use Authorizations (Updated)
- MQSA National Statistics (Updated)
- Federal Register: Hematology and Pathology Devices; Classification of the Software Algorithm Device to Assist Users in Digital Pathology
January 31, 2023
January 30, 2023
- Class I Recall: Medtronic Recalls Mahurkar Acute Dual Lumen High Flow Hemodialysis Catheters for Potential Catheter Hub Defect
- Surveying, Leveling, and Alignment Laser Products - Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Surveying, Leveling, and Alignment Laser Products
- Federal Register: Cardiovascular Devices; Classification of the Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate
January 27, 2023
- Monkeypox (mpox) and Medical Devices (Updated)
- Health Canada and FDA eSTAR Pilot (Updated)
- Class I Recall: LivaNova (TandemLife) Adds to Recall for LifeSPARC System that May Experience Unintentional Extended Pump Stops Due to Controller Critical Failure
- Federal Register: Premarket Approval of Medical Devices
January 26, 2023
- CDRH 2022 Annual Report
- Class I Recall: Emergent Recalls Certain RSDL (Reactive Skin Decontamination Lotion) Kits Due to Leak Potential
January 25, 2023
- GUDID Data Trends (Updated)
- Class I Recall: Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk That Blood May Enter Pump Through Damaged Balloon Catheter, Causing Patient Harm
January 24, 2023
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- CareStart COVID-19 Antigen Test (Access Bio, Inc.)
- InteliSwab COVID-19 Rapid Test Pro (OraSure Technologies, Inc.)
- Celltrion DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
- Celltrion DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
- Speedy Swab Rapid COVID-19 Antigen Self-Test (Watmind USA)
- cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
- CDRH Petitions (Updated)
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- For Consumer information: Agilent Resolution CtDX FIRST - P210040
- Transcript: October 26-27, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
January 23, 2023
January 20, 2023
- Medtronic HeartWare Ventricular Assist Device (HVAD) System (Updated)
- Recalls Related to the HVAD System (Updated)
January 19, 2023
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- CDRH Learn (Updated)
- Presentation, Transcript and Printable Slides: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkeypox (mpox) and COVID-19 - January 11, 2023
- Federal Register: Gastroenterology-Urology Devices; Classification of the Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal Conditions
- Federal Register: Ophthalmic Devices; Classification of the Intense Pulsed Light Device for Managing Dry Eye
- Federal Register: Records and Reports for Radiation Emitting Electronic Products; Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products
January 18, 2023
- FDA Seeks Public Comment: Advancing Real-World Data and Real-World Evidence with User Fee Funding (MDUFA V)
- Federal Register: Adverse Event Program for Medical Devices (Medical Product Safety Network)
January 17, 2023
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorization
January 13, 2023
- ASCA-Recognized Accreditation Bodies (Updated)
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Federal Register: Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Liver Related Disease Progression
January 12, 2023
- New Emergency Use Authorization
- Revised Emergency Use Authorizations
- Webinar: Electromagnetic Compatibility (EMC) of In Vitro Diagnostic Devices, February 2, 2023
- Policy for Coronavirus Disease-2019 Tests (Revised) - Guidance for Developers and Food and Drug Administration Staff
- Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised) - Guidance for Test Developers and Food and Drug Administration Staff
- Hearing Aids (Updated)
- Federal Register: Neurological Devices; Classification of the Digital Therapy Device to Reduce Sleep Disturbance for Psychiatric Conditions
January 11, 2023
- New Emergency Use Authorization
- Updated Emergency Use Authorizations
- Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Photobiomodulation Devices--Premarket Notification Submissions
January 5, 2023
- Revoked Emergency Use Authorization
- Federal Register: Cardiovascular Devices: Classification of the Hardware and Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate
- Federal Register: Ear, Nose, and Throat Devices: Classification of the Powered Insertion System for a Cochlear Implant Electrode Array
- Federal Register: Orthopedic Devices: Classification of the Resorbable Shoulder Spacer
- Federal Register: Physical Medicine Devices: Classification of the Electroencephalography-Driven Upper Extremity Powered Exerciser
- Federal Register: Physical Medicine Devices: Classification of the Virtual Reality Behavioral Therapy Device for Pain Relief
January 4, 2023
- Federal Register: Neurological Devices; Classification of the Brain Stimulation Programming Planning Software
- Federal Register: Orthopedic Devices; Classification of the Bone Indentation Device
- Federal Register: Orthopedic Devices; Classification of the Implantable Post-Surgical Kinematic Measurement Knee Device
January 3, 2023
- MQSA National Statistics (Updated)